About this trial
The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is:
• Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids?
The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids.
The participants will:
* Take semaglutide or a placebo every week for 12 weeks * Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires * Complete smartphone surveys sent at set times during the study
Eligibility criteria
Qualifiers
Age 18 to 75 years.
Body mass index (BMI) > 18.
Able and willing to provide informed consent prior to any study-related activities.
Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis. Patients are eligible if they have a MINI > 3 ("moderate" or "severe" in the "Specify If" box in the Substance Use Disorder (Non-Alcohol) module for the category of opiates).
Disqualifiers
Age < 18 or > 75 years.
BMI <18.
Individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.
Current use of glucagon-like peptide 1 receptor (GLP-1R) agonist.
Trial design
Treatments tested in this trial
- Semaglutide Pen Injector
- Placebo
Treatment groups
Locations
3Sponsors and collaborators
Milton S. Hershey Medical Center
Lead sponsor
New York University
Collaborator
University of Maryland
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator